Senior Statistician
Location: Alderley Park (home working may be considered)
Contract Duration: 11 months
Remuneration: competitive
The role:
Principal Statisticians provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies.
The Principal Statistician is responsible for:
• Delivery of strategic input, either in a specific therapeutic area or area of expertise
• Provision of statistical support and leadership to project teams
• Define and lead analysis of relevant internal and external information to inform design decisions
• Develop design options that address cost time uncertainty and probability of success with the appropriate use of modelling and simulation or other techniques to enable the business to make informed decisions.
• Application of expert statistical skills to provide support to the regulatory submissions including specification and construction of overview documents, responses to regulatory questions, and representation at Health Authority interactions.
• Lead the development and application of statistical methodology or related business process to improve the quality, efficiency and/or effectiveness of the Group and provide practical solutions for clinical development activities
Requirements –Education and Experience:
• MS/MSc/PhD in Statistics or Medical Statistics, or equivalent, with experience as a statistician in the health care environment or relevant areas of statistical applications or relevant areas of statistical applications.
• Substantial industrial experience at Senior Statistician or equivalent level
• Proven experience of study design from all phases of drug development or extensive experience of study design for regulatory submissions or extensive experience of study design is a specialised area
• Experience of quantification of benefit, risk, value and uncertainty
• Experience of effective use of modelling and simulation to improve clinical programme design and decision making
• Experience of analysis of data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, from different phases of development or in depth knowledge of relevant strategic capability area
• Experience of regulatory submissions and commercial support.
• Knowledge of Pharmaceutical drug development and marketing
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